Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)

Hypertension Clinical Trial

— TANDEM  

Official title:

A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234871
• Other study ID #: M03-599
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 11, 2008
• Start date: January 2004

Study information

• Verified date: July 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes

• Hypertension

• Albuminuria

Exclusion Criteria:

• Type 1 DM.

• Subject has severe hepatic dysfunction at Screening as determined by liver function tests:

• Bilirubin > 2.0 mg/dL.

• ALT and/or AST > 3 times the upper limit of normal.

• Subject has poorly controlled diabetes, based on HbA1c > 10% at Screening.

• Subject has non-diabetic renal disease.

• Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Proteinuria

Intervention

Drug:
• trandolapril/verapamil
2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
• Lotrel (amlodipine/benazepril)
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in urinary albumin:creatinine ratio		36 weeks	Yes
Secondary	Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events.		36 weeks	Yes